FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12337–12360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2022
Wireless TENS/EMS, Bruno, Aela
K220997 · NUH
Zmi Elecronics , Ltd.
Neurology · 150d
Cleared Sep 01, 2022
Disposable Medical Masks
K221038 · FXX
Hantech Medical Device Co., Ltd.
General Hospital · 147d
Cleared Sep 01, 2022
DrAid for Radiology v1
K221241 · QFM
Vinbrain Joint Stock Company
Radiology · 125d
Cleared Sep 01, 2022
Erchonia GVL
K221987 · NHN
Erchonia Corporation
General & Plastic Surgery · 57d
Cleared Aug 31, 2022
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
K210935 · HRS
I.T.S. GmbH
Orthopedic · 520d
Cleared Aug 31, 2022
Vented Vial Adapter 20mm
K213513 · LHI
West Pharma Services Il, Ltd.
General Hospital · 302d
Cleared Aug 31, 2022
QT Scanner 2000 Model A
K220933 · IYO
Qt Imaging, Inc.
Radiology · 153d
Cleared Aug 31, 2022
Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)
K221040 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 146d
Cleared Aug 31, 2022
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
K221255 · EBF
Kerr Corporation
Dental · 121d
Cleared Aug 31, 2022
INHANCETM Reverse Glenoid Peripheral Posts
K221467 · PHX
Depuy Ireland UC
Orthopedic · 103d
Cleared Aug 31, 2022
MyClearALIGN Dental Aligner System
K221475 · NXC
Key Dental Technologies, LLC
Dental · 103d
Cleared Aug 31, 2022
Disposable Blood Lancet
K221507 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 100d
Cleared Aug 31, 2022
LimFlow ARC
K221541 · PDU
LimFlow, Inc.
Cardiovascular · 96d
Cleared Aug 31, 2022
IPL sapphire ice cooling hair remove device
K221635 · OHT
Shenzhen Desida Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 31, 2022
Sterile Posterior Spinal Fixation System
K221745 · NKB
Shanghai Reach Medical Instrument Co,...
Orthopedic · 76d
Cleared Aug 31, 2022
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
K221955 · MUH
Realcloud Imaging Inc. Dba Realcloud...
Radiology · 57d
Cleared Aug 31, 2022
8ch Wrist Coil
K222325 · MOS
Invivo Corporation (Business Trade...
Radiology · 29d
Cleared Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K222387 · LNH
Canon Medical Systems Corporation
Radiology · 23d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile...
K212846 · FMF
Jiangsu Jichun Medical Devices Co., Ltd.
General Hospital · 357d
Cleared Aug 30, 2022
SOL-GUARD Safety Pull Button Collection Set
K213718 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 279d
Cleared Aug 30, 2022
Riva Cem Automix
K214118 · EMA
Sdi Limited
Dental · 243d
Cleared Aug 30, 2022
Medical Surgery Mask, Model:2626-7
K220067 · FXX
Dongguan Missadola Technology Co., Ltd.
General Hospital · 232d